Tissue repair implant and delivery device and method

ABSTRACT

A device having an implant driver configured to anchor a first implant to a first portion of tissue and to anchor a second implant to a second portion of tissue, the first and second anchors being coupled to respective first and second sutures, and a winder configured to twist the first and second sutures together as the sutures are refracted, thereby bringing the first portion of tissue into approximation with the second portion of tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 61/296,868, filed on Jan. 20, 2010, which isexpressly incorporated herein in its entirety by reference thereto.

Further, each of the following is hereby incorporated in its entirety byreference thereto: U.S. patent application Ser. No. ______, AttorneyDocket No. 14895/3, filed on Jan. 20, 2011, U.S. patent application Ser.No. ______, Attorney Docket No. 14895/5, filed on Jan. 20, 2011; andU.S. patent application Ser. No. ______, Attorney Docket No. 14895/6,filed on Jan. 20, 2011.

FIELD OF THE INVENTION

The present invention relates to a tissue implant and delivery deviceand method.

BACKGROUND INFORMATION

Some surgical interventions require the approximation of a first tissueand a second tissue. Known devices for drawing two tissues toward eachother require instrument access to the outer surfaces of the tissuesbeing brought toward each other. For example, where the two tissues arepart of the same organ, these instruments require access from theoutside of an organ where the tissues are part of the same organ. Thismay lead to trauma to surrounding tissues and increase the risk ofinfection. Thus, there is a need for a less invasive device and methodfor approximating two tissues.

Moreover, there is a need for a tissue approximation mechanism andmethod that is simple to operate and only requires access to the spacebetween the tissues being approximated. Further, there is a need for areliable tissue approximating mechanism that may be preciselyimplemented.

Further, there is a need for a mechanism and method that reducesprocedural costs and allows access to difficult-to-reach locations ofthe anatomy.

SUMMARY

According to example embodiments of the present invention, a surgicaldevice comprises an implant driver configured to anchor a first implantto a first portion of tissue and to anchor a second implant to a secondportion of tissue, the first and second anchors being coupled torespective first and second sutures, and a winder configured to twistthe first and second sutures together as the sutures are retracted,thereby bringing the first portion of tissue into approximation with thesecond portion of tissue.

The implant driver may be configured to anchor the implants by using ahydraulic driver. The hydraulic driver may use saline as a hydraulicfluid.

The device may further comprise a clamping element configured to clamptogether the sutures after the winding. The clamping element may befurther configured to trim the an excess length of each suture disposedproximally to a location of the clamping.

The first implant and/or second implant may be a fastener having aplurality of anchoring filaments configured to resist retraction of thefastener from the first portion of tissue.

At least one of the implants may be a fastener having a plurality ofwings configured to resist retraction of the fastener from the firstportion of tissue.

At least one of the implants may be a self-expanding anchor.

At least one of the implants may be disk-shaped.

The self-expanding anchor may include a plurality of tissue-piercingteeth configured to penetrate the entire thickness of the first portionof tissue.

According to example embodiments of the present invention, a surgicaldevice comprises a hollow needle having an inner chamber and a sharp tipconfigured to pierce a tissue, a first self-expanding anchor having acollapsed position and an expanded position, the first anchor beingpositionable within the inner chamber when in the collapsed position, afirst suture extending through the needle and attached to the firstanchor, and an actuator configured to drive the needle containing thefirst anchor into a first predetermined position in a first portion oftissue, wherein the needle is retractable from the first predeterminedposition to leave the first anchor in the first predetermined position,the first anchor expanding from the collapsed position to the expandedposition upon retraction of the needle.

The device may further comprise a second self-expanding anchor having acollapsed position and an expanded position, the second self-expandinganchor being positionable within the inner chamber when the secondself-expanding anchor is in the collapsed position, and a second sutureextending through the needle and attached to the first anchor, whereinthe actuator is configured to drive the needle with the second anchorinto a second predetermined position in a second portion of the tissue,the needle being retractable from the second predetermined position toleave the second anchor in a position distally beyond the second portionof tissue, the second anchor expanding from the collapsed position tothe expanded position upon retraction of the needle. Each of the firstand second sutures may be a braided suture.

The device may include an actuator configured to distally retract thefirst suture and the second suture into a distal end of the device,thereby pulling the first anchor and the second anchor together, thepulling of the first anchor and the second anchor together causing thefirst portion of tissue to be pulled toward the second portion oftissue.

The sutures may be twisted as they are distally retracted.

The device may further comprise a clamp configured to join the firstsuture to the second suture and cut excess portions of the first sutureand the second suture distal to the joint of the first suture to thesecond suture.

According to example embodiments of the present invention, a surgicalsystem includes a first implant coupled to a first suture, a secondimplant coupled to a second suture, and an implant driver configured toposition the first implant in a first predetermined position in relationto a first tissue, and to position the second implant in a secondpredetermined position in relation to a second tissue, the implantdriver configured to draw the sutures together to bring the implantsinto apposition thereby bringing the first tissue and the second tissueinto apposition, wherein the implants are configured to pierce both thefirst tissue and the second tissue at an interface of the first andsecond tissues when the first and second tissues are in apposition.

The first implant may be a first disk and the second implant is a seconddisk.

The first disk may include a plurality of projections each configured tocut entirely through the first tissue and the second disk includes aplurality of projections each configured to cut entirely through thesecond tissue.

According to example embodiments of the present invention, a methodcomprises positioning a first implant in a first predetermined positionadjacent a first tissue, positioning a second implant in a secondpredetermined position adjacent a second tissue, bringing the first andsecond tissues into apposition by pulling the first and second implantsinto apposition with each other, and creating multiple puncture woundsin the first and second tissues with the first and second implants toallow the first and second tissues to heal together in the region of thepuncture wounds.

Further features and aspects of example embodiments of the presentinvention are described in more detail below with reference to theappended Figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrate the insertion and manipulation of a catheterinto an organ.

FIGS. 2A and 2B illustrate a needle extending from the catheter of FIGS.1A and 1B and piercing a tissue wall of the organ.

FIGS. 3A to 3C sequentially illustrate the opening of the needle anddeployment of a plate or implant from the needle.

FIGS. 4A to 4E sequentially illustrate the withdrawal of the needle fromthe tissue wall and into the interior of the catheter.

FIGS. 5A and 5B sequentially illustrate the re-maneuvering of thecatheter to a proximal position.

FIG. 6A illustrates the maneuvering of the catheter from the proximalposition to a second tissue wall of the organ.

FIG. 6B shows the piercing of the second tissue wall by the needle anddeployment of a second plate or implant.

FIG. 6C illustrates the retraction of the needle.

FIG. 7A illustrates the catheter after being maneuvered to the proximalposition.

FIGS. 7B and 7C sequentially illustrate the pulling together of the twoplates or implants.

FIGS. 7D and 7E sequentially illustrate the withdrawal of the catheterfrom the organ.

FIGS. 8A to 8E sequentially illustrate the retraction and twisting ofrespective lines or cords attached to each plate or implant.

FIGS. 8F to 8G sequentially illustrate the clipping and joining of therespective lines or cords attached to each plate or implant.

FIG. 9 illustrates surgical implants with piercing teeth.

FIG. 10A illustrates a surgical implant.

FIG. 10B is a cross-sectional view of the implant of FIG. 10A.

FIG. 10C is an illustration of a distal end portion the surgical implantof FIG. 10A.

FIG. 11 illustrates a needle configured to carry an anchoring fastener.

FIG. 12 illustrates a distal tip portion of an anchoring fastener.

FIG. 13 illustrates an anchoring fastener with wings.

FIG. 14 is a schematic illustration of a surgical device to approximatetissues with anchoring fasteners.

FIG. 15A illustrates the driving of an anchoring fastener through afirst tissue and into a second tissue using the device of FIG. 14.

FIG. 15B illustrates the first and second tissues of FIG. 15A with theanchoring fastener implanted in the first tissue and the suture attachedto the anchoring fastener extending through the first tissue.

FIG. 15C illustrates the first and second tissues of FIG. 15B with asecond anchoring fastener driven through the second tissue and into thefirst tissue and with the device twisting the sutures attached to theanchoring fasteners.

FIGS. 15D to 15F sequentially illustrate the retraction, twisting, andclamping of sutures attached to the anchoring fasteners of FIG. 15C tojoin the two tissues.

FIG. 15G shows fasteners driven into the tissues at angles and locationsthat differ from the procedure of FIGS. 15A to 15F.

DETAILED DESCRIPTION

FIGS. 1A to 8G illustrate an implant device or catheter 3000 that ismaneuverable between two opposed layers 951 and 952 of tissue 950 inorder to close or narrow a gap or distance between the opposed layers951 and 952 of tissue 950. Referring to FIG. 1A, the implant device 3000is maneuvered between a first layer 951 of tissue 950 and a second,opposed layer 952 of tissue 950. The tissue may be, e.g., tissue of astomach. As illustrated in FIG. 1B, the distal end of the housing 3001of the catheter or implant device 3000 is maneuvered to be in proximityor contact with and directed toward the first layer 951 of tissue 950.The housing 3001 may be maneuvered by any appropriate mechanism, e.g.,guide wires.

After positioning and orienting the housing 3001, a sharp-pointedimplant-carrying needle or sleeve 3100 is distally extended from thehousing 3001 to pierce and penetrate the first layer 951 of tissue 950,as illustrated, e.g., in FIGS. 2A and 2B. The needle 3100 may be formedof, e.g., a shape-memory material, e.g., nitinol or spring-loaded steel.

After the needle 3100 has pierced and extended a distance beyond thefirst layer 951 of tissue 950, as illustrated in FIGS. 2A and 2B, thedistal portion of the needle 3100 expands, or flowers, outwardly, withfour adjacent extensions or leaves 3105 separated by longitudinal slitstherebetween, as illustrated, e.g, in FIG. 3A. Although four extensionsor leaves 3105 are provided, it should be understood that anyappropriate number may be provided. Moreover, the distal end of theneedle 3100 may have one or more elastic portions that provide analogousexpansion. It is noted that the needle 2100 described above may have astructure analogous to that of needle 3100 to allow for retraction ofthe sleeve 2100.

When the leaves 3105 open or expand outwardly, a button-like implant orplate 3200 is exposed from the interior of the needle 3100. The plate3200, which is formed, e.g., from a shape memory alloy such as, e.g.,nitinol, or spring-loaded steel, springs from a folded position thatallows for storage inside the non-expanded needle 3100, into a deployedor expanded position as sequentially illustrated in FIGS. 3A to 3C.

Although the plate 3200 has a flattened, cylindrical shape, it should beunderstood that the plate 3200 may be designed to have any appropriateshape and/or size depending on, e.g., the particular application.

After the plate 3200 is released and expanded, the needle 3100proximally retracts back into the housing 3001, as sequentiallyillustrated in FIGS. 4A to 4E. As the needle 3100 retracts, a cord 3300,e.g., a braided suture, which is attached to the plate 3200 and extendsinto and through the needle 3100 is exposed between the plate 3200 andthe needle 3100. Further, as the needle 3100 retracts, the cord 3300 ispulled distally to the extent that the plate 3200 contacts an exterioror distal surface of the first layer 951 of tissue 950, as illustrated,e.g., in FIG. 4C.

The cord 3300 is formed of a plurality of threads 3305, e.g., absorbableor non-absorbable suture material, that extend through various aperturesin the plate 3200 in a button-like manner to secure the cord to theplate 3200. It should be understood, however, that the cord 3300 may bea single strand and/or attached to the plate 3200 by any otherappropriate mechanism.

FIGS. 5A and 5B sequentially illustrate the re-maneuvering of thecatheter to a proximal position, while allowing a corresponding lengthof cord 3300 to be distally released from the housing 3001.

FIG. 6A illustrates the maneuvering of the catheter from the proximalposition to a second wall or layer 952 of tissue 950 of the organ, thesecond layer 952 being opposed and spaced apart from the first layer 951of tissue 950. FIG. 6B shows the piercing of the second layer 952 by aneedle 3100, which may be the same needle 3100 that pierced the firstlayer 951, or a second needle 3100 separate from the first needle 3100.FIG. 6B further shows the deployment of a second button-like implant orplate 3200 on the distal surface of the second layer 952 of tissue 950in analogous manner to the deployment of the first plate 3200 describedabove.

As illustrated in FIG. 6C, the needle 3100 is then retracted proximallyinto the housing 3001, which then returns to a proximal position asillustrated in FIG. 7A, in analogous manner to that described above,with a second cord 3300 being attached to the second plate 3200.

FIGS. 7A to 7C sequentially illustrate the pulling together of the twoplates or implants 3200 by drawing the two cords 3300 proximally intothe housing 3001, and joining and clipping the two cords 3300. Bydrawing the two cords 3300 into the housing 3001, the two plates 3200,each attached to a respective one of the cords 3300 are drawn together.As a result of the contact between the proximal faces of the two plates3200 and the respective distal faces of the two opposed layers 951 and952 of tissue 900, the layers 951 and 952 of tissue 950 are drawntogether, as illustrated, e.g., in FIG. 7C. After joining and clippingof the two cords 3300, the implanting device 3000 is retracted from thesurgical site, e.g., organ, as illustrated sequentially in FIGS. 7D and7E. Thus, the above procedure results in the implantation of twoopposed, button-like plates 3200 joined by cords 3300 to hold twoopposed layers 951 and 952 of tissue 950 in a drawn-together position,as illustrated, e.g., in FIG. 7D.

FIGS. 8A to 8G sequentially illustrate the pulling and clipping of thetwo cords 3300 by the implanting device 3000, which is illustrated incross section. Referring to FIG. 8A, the housing 3001 is in the proximalposition corresponding to FIG. 7A. Each cord 3300 extends into thedistal opening of the housing 3001 and along the length in the internalbore of the housing 3001. Each cord also extends into a distal openingof a tubular sleeve 3400, which is also disposed in the internal bore ofthe housing 3001. At a distal end of the tubular sleeve 3400 are a pairof hooked twisting arms 3405. As illustrated sequentially in FIGS. 8B to8E, the cords 3300 and the twisting arms 3405 are retracted proximallywith respect to the housing 3001, while the tubular sleeve 3400 rotatesabout its longitudinal axis. The rotation of the tubular sleeve 3400about its longitudinal axis causes the twisting arms 3405 to engage therespective cords 3300 and revolve around the longitudinal axis of thetubular sleeve 3400. The continued revolution of the twisting arms 3405causes the engaged cords 3400 to be continually and progressivelytwisted as the cords 3300 and the sleeve 3400 proximally retract, untilthe cords 3300 have reached their desired end position and therespective plates 3200 have reached their desired approximation, asillustrated in FIG. 8E. It is noted that the degree of retraction of thecords 3300 may be adjusted to achieve varying degrees of closure betweenthe two layers 951 and 952 of tissue 950. The hooked shape of thetwisting arms 3405 holds the cords a predetermined distance from thelongitudinal axis of the sleeve 3400. This allows for greater control ofthe twisting of the cords 3300.

Although the tubular sleeve 3400 rotates about its longitudinal axiswith respect to the housing 3001 and the tissue 950, it should beunderstood that both the housing 3001 and the sleeve 3400 may rotatewith respect to the tissue 950. For example, the sleeve 3400 may benon-rotatable, or substantially non-rotatable, with respect to thehousing 3001, with the sleeve 3400 proximally retracting with respect tothe housing 3001 and the tissue 950 as the sleeve 3400 and housing 3001rotate together to twist the cords 3300.

When the desired position of FIG. 8E is reached, the respective cords3300 are fastened together and trimmed by pair of clip members 3500. Theclip members 3500 are brought from an initial position, illustrated,e.g., in FIG. 8E, into contact with a distal portion of the twists ofthe cords 3300, as illustrated in FIG. 8F. In order to join and trim thecords 3300, the clip members 3500 are further closed until they locktogether and separate distal implant portions 3305 of the cords 3300from proximal excess portions 3310 of the cords 3300. At this stage, thelocked clip members 3500 are released from the distal end of theimplanting device 3000, thereby separating and releasing the implantedportions 3200, 3305, and 3500 from the implanting device 3000, allowingretraction and removal of the implanting device 3000 from the surgicalsite. Thus, the implanted portions are left in their implanted position,maintaining the first and second layers 951 and 952 of tissue 950 in thedesired approximation relative to each other.

Although the clip members 3500 simultaneously join the implantedportions 3305 of the cords 3300 and cut the excess portions 3310 fromthe cords 3300 (e.g., by opposed cutting members at proximal locationson the respective clip members 3500, which come together to separate theexcess portions 3310 as the implant portions 3305 are fastenedtogether), it should be understood that the excess portions 3310 may betrimmed at a different time and/or by a mechanism separate from the clipmembers 3500.

Further, although the implant portions 3305 are joined by clamping andlocking two opposed clip members 3500, it should be understood thatother joining mechanisms may be provided. For example, where, e.g., thecords 3300 are made of polymeric materials, the implant portions 3305may be welded or melted together, e.g., by application of heat,pressure, and/or high-frequencies.

The use of the plates 3200 may be particularly suitable for applicationswhere a structure has a cavity on the distal or opposite side of thelayer 951 or 952. However, in other applications, it may be preferableto replace one or more, e.g., all, of the plates 3200 with one of theanchoring fasteners, e.g., fasteners 250, 350, 550 described below. Inthis regard, the suture 3300 (e.g., a braided material) would beattached to the fastener 250, 350, 550, at the distal end thereof, asset forth in greater detail below, and extend into the distal end of thehousing, e.g., housing 3001, in the manner described above. Theremaining operation would be analogous to that described above withrespect to the plates 3200, with the sutures 3300 being retracted,joined, and trimmed. However, one or more (e.g., all) of the tissueportions would be pulled by the engagement of an anchoring fastener(e.g., fastener 250 or 300), rather than the button-like plate 3200. Thefastener may be deposited in any manner disclosed herein, including,e.g., directly firing the fastener into the tissue or insertion via aneedle such as, e.g., the needle 2100. It should be understood that morethan two implants (e.g., plates 3200 and/or fasteners, e.g., fasteners250, 350) may be provided, with more than two cords 3300 beingretracted, twisted and joined.

The cords/sutures 3300, plates 3200, and/or clip members 3500 may beformed entirely or partly of a bioabsorbable material, e.g.,polyglycolic acid (PGA), or a PGA copolymer.

FIG. 9 illustrates a pair of piercing pledgets or implants 4200. Thepiercing implants may be provided in a surgical system having all of thefeatures described above with respect to the surgical device 3000, withpiercing implants or disks 4200 being provided in place of the implants3200. Although both implants 3200 have been replaced by implants 4200 itshould be understood that one piercing implant 4200 may be used incombination with an implant 3200 described above.

As illustrated in FIG. 9, the implants 4200 have been deployed andsecured in the same manner described above with regard to implants 3200.It is noted that implants 4200, like implants 3200 are self-expandingand may be deployed from the needle 3100. For simplicity, the cords 3300and clip elements 3500 are not shown in FIG. 9.

The implants 4200 differ from the implants 3200 in that they are eachprovided with a plurality of tissue-piercing teeth 4205 extending fromthe surface that contacts the respective layers of tissue 951 and 952.These sharp pointed projections are interspersed, e.g., according to apredetermined density per unit area, over the tissue contacting face ofeach implant 4200. The teeth 4205 have a length selected to fullypenetrate the respective layer of tissue 951, 952. That is, the teeth4205 have a length that allows the sharp tip to penetrate and extendbeyond the opposed face of the tissue, e.g., the interior surface of anorgan where the tissues 951 and 952 are opposed walls of the same organ.This full penetration forms a wound that causes collagen to naturally beproduced from the tissue and flow, via the holes formed by the teeth4205, into the space between the two opposed tissues 951 and 952. Thisis advantageous in that it facilitates healing together of the twoapposed tissues 951 and 952.

FIGS. 10A and 10B illustrate a surgical micro implant or fastener 250that may be used in connection with a surgical system as describedabove. However, one or more of the disk-like implants 3200 and/or 4200are replaced by implant 250. FIG. 10B is a cross-sectional view of thesurgical implant 250 of FIG. 10A with a cross-sectional plane extendingalong and including the longitudinal axis of the fastener 250 of FIG.10A. The fastener 250 has the suture 3300 extending proximally from aproximal end 285 of the fastener body 255. In this regard, when a driverfires the fastener 250, e.g., by application a saline or other precisehydraulic force or any other appropriate mechanism, the depth to whichthe fastener 250 is driven is limited by the amount of slack in thesuture 3300. This may be accomplished by fixing a proximal end and/orother proximal portion of the suture 3300 to a structure, e.g., a fixedposition within the driver device, with a predetermined length and/orslack between the fixing location and the fastener body 255.

Referring to the cross-sectional view of FIG. 10B, the suture 3300 mayextend longitudinally into an interior location 290 of the fastener body255. An example manufacturing method may include molding, coextruding,or otherwise forming the fastener head 905 over the suture 3300. Itshould be appreciated however, that any appropriate manufacturing methodmay be employed. Further, although a suture 3300 of non-stretchablematerial is provided, it should be understood that other materials,e.g., stretchable materials, may be provided. However, it may bepreferable that, even if stretchable, the material have apredeterminable extension limit for particular driving momentums and/orapplications. Further, a braided, non-braided, mono-filament, and/ormulti-filament material may be provided.

Although the fastener 250 includes micro filaments 275 to anchor into atissue and resist proximal dislocation after implantation, it should beunderstood that any other anchoring mechanism, e.g., wings as describedabove, may be provided. Moreover, any of the features disclosed withregard to the other example implants disclosed herein may be provided inconjunction with the fastener 250.

FIG. 11 shows a needle 5600 that includes many features in common withneedle 3100 described above. However, the needle 5600 is configured toposition the fastener 250 to the predetermined location within thetissue 951, 952.

Further, it may be desirable to form the needle 5600 to have a smallerresting or initial diameter than the fastener contained therein. Forexample, as illustrated in FIG. 11, the needle 5600, when the fastener650, which is identical to fastener 250, is inserted into the needle5600, the metal bands 5605 bulge outwardly to form expanded gaps betweenthe adjacent metal bands 5605. This may be advantageous to allow thefilaments and/or other anchoring mechanism(s) to engage the adjacenttissue and resist proximal movement of the fastener as the needle 5600is retracted. For example, as illustrated in FIG. 11, the microanchoring filaments 675 of the fastener 650 are exposed through thelongitudinally extending gap between adjacent bands 5605 of the needle5600, thus allowing the filaments 675 to engage surrounding tissue evenat the initial stages of the retraction of the needle 5600. In thisregard, the engagement of the filaments 675 with the tissue may besufficient in and of itself to allow proximal retraction of the needle5600 while leaving the fastener 650 in its implanted position. It shouldbe understood, however, that other mechanisms, e.g, a push rod, may beprovided in connection with the needle 5600 to facilitate retraction ofthe needle 5600 while retaining the implant 650 in its predeterminedlocation. Since some applications do not require full penetration of theimplant, the needle 5600 may only need to penetrate to a depth that doesnot compromise or pierce the outer surface of the tissue 951, 952.

The discussion herein, including the discussion below, of the featuresof implant 250 also apply to the other implants 350, 550, 650 disclosedherein, except to the extent that any differences in features areexplicitly mentioned.

The surgical implants 250, which may be absorbable or non-absorbable,are designed to penetrate a viscera or tissue planes. The implants 250are designed to penetrate into the tissue under controlled rapiddeployment to a predetermined depth. The implant is shaped similarly toa needle with a predetermined geometry. Each implant 250 has anelongated body 255 that tapers in a distal region to a needle-like tip260. Each implant 250 may be deployed, e.g., by being pushed from aprecisely placed hollow needle or tube containing the implant 250. Theimplants 250, as well as any other example implants disclosed herein,may be formed using e.g., micromachining techniques.

The micro implants 250 may have a diameter of one millimeter, orapproximately one millimeter, and a length that is in a range from 5millimeters to 10 millimeters. According to example embodiments, thediameter is less than one millimeter. According to example embodiments,the diameter is in a range from 0.8 millimeters to 1.2 millimeters. Itshould be understood, however, that other dimensions may be provided.

The body 255 of each implant 250 has specifically designed microanchoring filaments 275 which arise from the core of the implant 250 toextend outwardly therefrom. The anchoring filaments 275 are locatedaround the circumference and along at least a portion of the length ofthe body 255 of the implant 250. This allows the implant 250 to resistremoval once it has penetrated the tissue.

The filaments 275 may have any suitable dimensions. For example, it maybe advantageous to provide a filament tip (i.e., free end) diameter of0.1 millimeters and tapering toward a diameter of 0.25 millimeters atthe body.

The core, which is, e.g., cylindrical, has a constant diameter along asubstantial length of the body 255 of the implant 250. For example, thecore of the implant 250 has a constant cross-section, and constantdiameter, from a proximal end to a substantially conically shapedtapered portion toward the tip 260. It should be understood however,that the implants 250 may have a more continuous taper and/or have aconstant or non-constant rate of taper.

The anchoring filaments 275 extend outwardly at an angle with respect tothe longitudinal axis of the implant 250. In this regard, the filaments,in addition to extending outwardly away from the longitudinal axis, alsoextend in a proximal direction, away from the tip 260. This allows forthe filaments 275 to slide along the pierced tissue during distaldriving or insertion. However, proximal movement of the implants 250from the inserted position is prevented or resisted by engagement of theouter, free ends of the filaments 275 with the relatively soft tissue.The filaments 275 may be flexible or substantially rigid. The filaments275 should, however, have sufficient stiffness or strength to resistproximal withdrawal of the implant 250 from the inserted position.Further, although the filaments 275 are illustrated as being straight,it should be understood that some or all of the filaments 275 may be atleast partially curved, and/or have one or more bends between straightportions and/or curved portions. Moreover, the filaments 275 of a givenimplant 250 may have constant or differing lengths, radial extensions,and/or angles with respect to the longitudinal axis of the implant 250.

The micro filaments 275 may be provided with any appropriate density andrelative spacing, depending on the particular application. For a givenapplication, a greater density (i.e., a greater number of filaments perunit of surface area) of smaller filaments may be provided, or a lesserdensity of larger filaments (optionally reinforced with a shape memoryalloy, e.g., nitinol and/or spring-loaded steel), while presenting thesame or comparable suture retention or “pull through strength.” Theoptional reinforcement could be a “V” shaped portion formed of shapememory alloy, e.g, nitinol and/or spring-loaded steel. The filaments 275may be absorbable or non-absorbable in whole or in part.

Although the fastener 250 uses micro filaments 275 to anchor thefastener 250 into the tissue, it should be appreciated that anyappropriate anchoring mechanism may be provided. for example, springloaded tabs may be provided.

Each implant 250 has a proximal surface 285 via which a driving forcemay be applied, e.g., by saline hydraulics, a spring force or any otherappropriate mechanism. The proximal surface 285 of the implant 250corresponds to the surface from which the suture 3300 proximally extendsand is the same or substantially the same as the diameter of the core220. However, any appropriate location or dimensions may be provided forthe surface 285.

Although the implants 250 have cores with circular cross sections, itshould be understood that other cross-sections may be provided, e.g.,rectangular, triangular, oval, polygonal, and/or any other regular orirregular shape. Further, it should be understood that the anchoringmicro filaments 275 may be evenly spaced apart or may have non-uniformspacing. Moreover, the filament density, i.e., the number of thefilaments 275, 575, 675 per unit of surface area of the core may beconstant, or may vary.

FIG. 12 shows a distal end portion of an implant 550, which is identicalto the implant 250 except for the distal end portion illustrated in FIG.12. The distal arrangement includes three concave surfaces 580 thatdistally converge to form the sharp point 560. Separating the threeconcave surfaces 580 are three tapered cutting edges 585. These taperedcutting edges 585 may facilitate penetration of tissue, e.g., softtissue. Although the end portion illustrated in FIG. 12 includes threeconcave surfaces 580 separated by three corresponding tapered cuttingedges 585, it should be understood that any appropriated number ofconcave surfaces 580 and corresponding cutting edges 585 may beprovided.

Moreover, FIG. 13 illustrates a surgical micro implant or fastener 350that has features in common with the fastener 250 and may be used inconjunction with any of the fastening applications described herein.However, the fastener 350 includes a corrugated body 351. The body 351includes grooves 353 that extend axially along the length of the body351. Thus, extending circumferentially around the body 351, a pluralityof grooves 353 alternate with a plurality of ridges 355. Further, thefastener body 351 includes a pair of split portions or wings 357 and358. The split portions are formed by respective splits or cuts 359 intothe body 351. In this regard, the splits 359 may be formed by making acut radially into the body 351 and extending in an axial direction.Thus, the two split portions 357 and 358 are attached to the remainderof the body 351 at a distal position and extend proximally to free ends.The free ends include a plurality of sharp protrusions along a curvedsurface. These points are formed due to the corrugations. In particular,the ridges 355 form the sharp protrusions. In particular, the ridges 355form the sharp protrusions, as illustrated in the inset partial sideview in FIG. 13, which are advantageous for gripping tissue andpreventing distal sliding of the fastener 250. Although each splitportion 357 and 358 includes three such protrusions as illustrated, itshould be understood, that the fastener 350 may be designed such thatone or more of the split portions has any other number of protrusions,including a single sharp protrusion. For example, if a larger number ofsharp protrusions are desired, the body 351 could be more denselycorrugated (i.e., a greater number of alternating grooves 353 and ridges355 could be provided) and/or the angle of the cut or slice could beadjusted. Further, the length of proximal extension of the projectionsmay be adjusted by varying the depth of the grooves 353 with respect tothe ridges 355.

The split portions 357 and 358 do not substantially impede distalinsertion into tissue but resist proximal movement from an insertionlocation by engaging the tissue. It has been discovered that thecombination of the pointed and/or sharp-edged proximal ends of the splitportions 357 and 358 with the alternating ridges on the proximal end ofthe split portions creates improved performance.

Further, the split portions or wings 357 and 358 are axially offset fromeach other. For example, split 357 is axially located at position aalong axis x and split 358 is axially located at position b along axisx. This allows for greater structural strength of the other portions ofthe body 351 as compared to a non-offset configuration. In particular,since the cuts progress continually radially inward as they progressdistally, a non-offset portion would have a substantially smaller amountof material in cross-section in the distal end of the cut. This wouldlead to a mechanically weak point or region along the axis of the bodyand could lead to mechanical failure, especially in fasteners of smalldimensions.

The distal tip of the fastener 350 is pyramidal, with a sharp point, anda plurality of surfaces separated by edges that converge at the sharppoint. Although four planar surfaces are provided, it should beappreciated that any appropriate suitable number of surfaces may beprovided and that one or more or all of the surfaces may be non-planar.

The fastener 350 also includes a hooked end portion 360. The hookedportion may be suitable for coupling any other temporary and/orpermanent implant. For example, the hook may be used to secure thesuture 3300. However, the fastener 350 may advantageously be formed withthe suture 3300 extending therewith, e.g., by being molded orco-extruded with the suture 3300, as described with regard to fastener250. Moreover, the hooked end portion may be dispensed with.

The fastener 350 may be produced by first forming the body 351 with thecorrugations, e.g., by injection molding or extrusion, and subsequentlyforming wings 357 and 358, e.g., by cutting radially into the side ofthe body 351. As illustrated, the cut is curved, with an angle (at theproximal entry point), relative to the longitudinal axis of the body351, that gradually decreases from the proximal initial cutting locationtoward the distal end of the fastener 350 and eventually becominglinear. Although the spit or cut of the illustrated example is made witha curved or varying angle with respect to the longitudinal axis of thebody 351, it should be understood that any appropriate cut, including alinear cut, may be made.

Although the fastener 350 includes two wings spaced equally around theradial periphery of the body 351, it should be appreciated that anynumber of wings, including a single wing may be provided and at anyappropriate spacing around the radial periphery.

Furthermore, it should be understood that the corrugated split-bodiedconfiguration may be employed in combination with any of the otherfastener features disclosed herein. For example, the fastener 350 mayinclude filaments in addition to the split portions.

Referring to FIG. 14, a surgical system 5000 includes a handpiece 5100configured to drive the fastener 250, for example, to a predetermineddepth. The depth is limited, e.g., by a predetermined amount of slack inthe suture 3300. The proximal end of the suture 3300 is attached to acapstan 5105 configured to adjust the length of the suture 3300extending from capstan 5105. In this regard, the capstan 5105, which maybe actuated by a motor system or any other appropriate mechanism, mayset the slack by reeling off a predetermined length of suture 3300 priorto driving the fastener 250 and/or the capstan 5105 may have apredetermined amount of allowed rotation such that driving of thefastener 250 causes the capstan to rotate only the predetermined amount,thereby setting the driving depth of the fastener 250. The determinationof the depth and/or the driving velocity of the fastener 250 may bedetermined in a processor 5110 of the handpiece 5100. The device 3000described above may include an analogous handpiece. Although theprocessing takes place in a processor 5110 located in the handpiece5100, it should be understood that the processor may be disposed inother parts of the device, e.g., in the shaft 5115 and/or the processingmay take place location separate from the handpiece 5100 and shaft 5115,e.g., at a remote computing unit that communications, e.g., wirelessly,with the surgical device. Further, it should be understood that thecapstan 5110 may be disposed in the shaft 5115.

The shaft 5115 includes many features, e.g., the maneuverability, thewinding mechanism and the clipping mechanism, of the catheter 3000described above.

During a procedure, the system 5000 operates in a manner analogous tothe device 3000 described above. However, one or more of the implants3200 are replaced by the implants 250. The implants 250 may behydraulically delivered, or delivered by a piercing needle, or any otherappropriate driving mechanism. Regarding hydraulic delivery, it is notedthat a very precise force may be delivered at the distal end portion ofthe shaft 5115 to drive the fastener 250. This force may be controlledby the processor 5110 in connection with hydraulics, e.g., in thehandpiece. For example, the hydraulic fluid, e.g., saline, may bedisposed in a tube extending along the shaft 5115. Hydraulics andcontrols in the handpiece 5100 may then transmit a very precise force,via the hydraulic fluid extending along the shaft 5115, to the distalend portion of the shaft 5115 to precisely drive the fastener 250.

As illustrated in FIG. 14, the fastener 250 has been driven into thetissue 951, 952. As the shaft is retracted from the implantationlocation, e.g., to be repositioned at the opposed layer of tissue, thecapstan 5105 reels off a corresponding length of suture 3300. Furtherafter driving a second implant, e.g., another fastener 250, the twosutures 3300 are wound in the manner described above with respect todevice 3000. During the winding the capstan may be actuated, e.g.,according to control signals from the processor 5110 to progressivelyretract the suture 3300. However, the capstan may be controlled toresist any rotation, e.g., where the capstan is mounted to move inconnection with a retracting winding tube such as the tube 5400described below. Each suture 3300 may have its own respective capstan5105 or the sutures 3300 may share a capstan mechanism. If the sutures3300 share a capstan mechanism, it may be advantageously be configuredwith a mechanism to retract/extend each suture 3300 independently, e.g.,during the fastener driving procedures. Moreover, the capstan(s) 5105may be coupled to the suture twisting mechanism to avoid any undesiredtwisting proximal to the twisting interface, e.g, hooks.

FIG. 15A illustrates the driving of an anchoring fastener 250 through afirst tissue 1951 and into a second tissue 1952 using the device of FIG.14.

FIG. 15B illustrates the first and second tissues 1951, 1952 of FIG. 15Awith the anchoring fastener 250 implanted in the first tissue and thesuture 3300 attached to the anchoring fastener 250 extending through thefirst tissue 1951.

FIG. 15C illustrates the first and second tissues 1951, 1952 of FIG. 15Bwith a second anchoring fastener 250 driven through the second tissue1952 and into the first tissue 1951 and with the device of FIG. 14Atwisting the sutures 3300 attached to the anchoring fasteners 250.

FIGS. 15D to 15F sequentially illustrate the retraction, twisting, andclamping of sutures attached to the anchoring fasteners of FIG. 15C tojoin the two tissues.

FIG. 15G shows fasteners driven into the tissues at angles and locationsthat differ from the procedure of FIGS. 15A to 15F.

FIGS. 15D to 15F sequentially illustrate an approximation procedureemploying the fasteners 250. As illustrated in FIG. 15C, the fasteners250 have been driven into the opposed tissues 1951 and 1952 and thesutures 3300 are in the process of being refracted and twisted in manneranalogous to that described above with respect to device 3000. Withinthe tube portion 5115 is a winding tube 5400 that rotates and retracts,along with its winding hooks 5405 to wind and retract the sutures 3300.A pair of actuatable clip elements 5500 are disposed at the distal endportion of the tube 5115. These elements 5400, 5405, and 5500 havefeatures analogous to elements 3400, 3405, and 3500 described above withregard to device 3000.

As illustrated in FIG. 15D, the sutures 3300 are in a taut state as thetissues 1951, 1952 are moving toward each other due to the twisting andretraction of the proximal portions of the sutures.

As illustrated in FIG. 15E, the tissues 1951, 1952 have been broughtinto contact with each other and are being held securely by the sutures3300.

As illustrated in FIG. 15F, the clip elements 5500 have been actuated toclip and join the sutures 3300 in the same manner described above withregard to clip members 3500.

It is noted that this arrangement does not require penetration of fullthickness of the respective tissues 1951 and 1902 into which theimplants 250 are implanted. That is, the sharp tips of the anchoringfasteners are not exposed beyond the outer walls of the tissue need notbe pierced. This may be advantageous to reduce trauma to the tissue andlimit the possibility of damaging any adjacent tissues. It should beunderstood, however, that the fasteners 250 may be driven to a depthsuch that the tip extends beyond the outer wall of the respective tissue1951, 1952 into which the respective fastener is implanted.

The arrangement of FIG. 15F maintains a closure that secures theillustrated end portions of the two tissues 1951, 1952 together.

FIG. 15G shows an arrangement that is analogous to the arrangement ofFIGS. 15A to 15F, but differs in that the angle between the axes alongwhich the fasteners 250 are driven is less. Further, the fasteners 250are driven through end faces of the tissues 1951, 1951. In this regard,it should be understood that the fasteners 250 may be driven at anyappropriate angle (including, e.g., substantially 180 degrees) to eachother and at any appropriate angle or location with respect to therespective tissues 1951, 1952.

The driver of any example implants disclosed herein may be configured todrive any of the example fasteners described herein to a predetermineddepth. The precision of the depth may be accomplished by any appropriatemechanism, e.g., a precise hydraulic driving force, e.g., with salinefluid, engagement with flanges or other similar stops, or a suture thattautens to limit the depth. Further the depth may be monitored usingfluoroscopy or any other appropriate imaging mechanism. The drivingmechanism may include pressurized saline or other hydraulic fluid thatis pressurized through the endoscopic catheter shaft. Thus, very precisecontrol may be accomplished.

According to example embodiments, a computer system, e.g. includingprocessor 5110, may determine the location of two points, e.g., anddetermine a distance therebetween. The distance may be used as a desireddistance to which the fastener is fired. The implanting distance may beset by any appropriate adjustment mechanism, e.g., an adjustable stop orflange, a cord or suture attached to the fastener, and/or preciselycontrolling the speed and momentum of the fastener during theimplantation (e.g., by finely controlling a hydraulic propulsionsystem). Such measurements, determinations, and/or control of depth maybe employed in conjunction with any implantation of fasteners disclosedherein.

The fasteners are preferably driven at a speed greater than 50 metersper second, more preferably in a range of 50 to 350 meters per second,and most preferably at 350 meters per second. However, it should beunderstood that the fasteners may be driven at any suitable speedsufficient for the fasteners to puncture tissue.

Modern manufacturing processes allow for near nano technologyapplications. This allows the implant 250 and any other implantsdisclosed herein to be manufactured in a size and complexity that maynot have been possible in years past. The implant 250 may be injectionmolded of either absorbable or non absorbable polymers and thenprocessed to add the features of the protruding filaments 275.

Although the implants 250 are formed of polymer, it should beappreciated that any appropriate material may used, e.g., metal or acomposite material.

In order to accurately penetrate adjacent tissues that are not held orsecured on a distal side, a rapid penetration of the layer(s) of tissuemay be required in order to effect a desired penetration. If an implant250 is applied slowly, the tissue may be pushed distally away by theimplant and/or needle without adequate penetration. Thus, some exampledelivery mechanisms eject the implant a relatively high velocity. Insome preferred examples, saline is used to pressurize the channel withinthe catheter or needle at such a rate that the plunger will eject theimplant 250 at the precise velocity. Other example embodiments utilize aspring-loaded mechanical mechanism to eject the implant. Further exampleembodiments push the implant using long push rods which run the lengthof the catheter. The ejection modality is computer-controlled. However,it should be understood that the ejection may be, e.g.,operator-controlled. For example, the ejection force may bepredetermined and repeatable by a mechanical system, e.g., aspring-loaded system, which is triggered by an operator, e.g., asurgeon.

Any of the mechanisms and devices described above may be utilized withpressure sensing, e.g., sensing of the pressure required to progress aneedle or fastener using any appropriate pressure sensing mechanism. Thepressure may be relayed to, e.g., a computer control system, including,e.g, processor 5110, in a hand piece, e.g., handpiece 5100, to which theimplanting device of any of the embodiments described herein is coupled.Further, imaging data may be obtained, including, e.g., ultrasound orother digital imaging, and relayed to, e.g., the computer control systemin a hand piece. This information, including pressure and/or imaginginformation and/or any other sensed information may be used by thecontrol system to appropriately control the insertion of the variousneedles and/or implants into the tissue. For example, the control systemmay control the rate, location, angle, and/or depth of insertion. Suchprecise control may be particularly advantageous when repairing defectsin the heart, which requires very precise placement of implants.

The various mechanisms described herein provide for a tissue repairsystem that allows great flexibility. For example, smaller defects maybe repairable with a single fastener (e.g., fastener 100 or any otherfastener described herein), and larger defects may be repairable with aplurality of fasteners, with or without a washer or plate 2200, asdescribed above. Larger defects, e.g., hernias or large holes, may bemore suited for a mesh 1300 application, as described above.

The various implants described herein, e.g., fasteners 250, 350, 550,650 plates 3200, and clip elements 3500, 4500, may be formed by molding,e.g., injection molding.

Moreover, the fasteners 250, 350, 550, 650 may be provided with a headelement that restrains proximal movement of the tissue with respect tothe fastener. Further, the head elements may be fixed or movable, e.g.,where the fasteners have ratcheted or threaded proximal end portionsconfigured to receive corresponding ratcheting or threaded headelements.

Further, any of the implantable elements described herein, e.g.,fasteners 250, 350, 550, 650, plates 3200 4200, and clip elements 3500,5500, and/or sutures 3300, may be formed wholly or partly of a materialabsorbable into the patient's body, or of a non-absorbable material,depending on, e.g., the specific application. For example, theseelements may be formed of polyglycolic acid (PGA), or a PGA copolymer.These elements may also, or alternatively, be formed of copolymers ofpolyester and/or nylon and/or other polymer(s). Moreover, these elementsmay contain one or more shape-memory alloys, e.g., nitinol and/orspring-loaded steel.

Absorbable materials may be advantageous where there is a potential formisfiring or improper locating of the various implants. For example, ina situation where a fastener or other implant is driven at an unintendedlocation, or where the tissue does not properly receive the implant, theimplant even where not needed, would relatively harmless, as it wouldeventually absorb into the patient's body.

Although the present invention has been described with reference toparticular examples and exemplary embodiments, it should be understoodthat the foregoing description is in no manner limiting. Moreover, thefeatures described herein may be used in any combination.

1. A surgical device, comprising: a first anchor coupled to a firstsuture; a second anchor coupled to a second suture; an implant driverconfigured to anchor a first implant to a first portion of tissue and toanchor a second implant to a second portion of tissue, the first andsecond anchors being coupled to respective first and second sutures; anda winder configured to twist the first and second sutures togetherbringing the first portion of tissue into approximation with the secondportion of tissue.
 2. The device of claim 1, wherein the implant driveris configured to anchor the implants by using a hydraulic driver.
 3. Thedevice of claim 2, wherein the hydraulic driver uses saline as ahydraulic fluid.
 4. The device of claim 1, further comprising clampingelement configured to clamp together the sutures after the winding. 5.The device of claim 4, wherein the clamping element is furtherconfigured to trim the an excess length of each suture disposedproximally to a location of the clamping.
 6. The surgical device ofclaim 1, wherein the first implant is a fastener having a plurality ofanchoring filaments configured to resist refraction of the fastener fromthe first portion of tissue.
 7. The surgical device of claim 1, whereinthe first implant is a fastener having a plurality of wings configuredto resist retraction of the fastener from the first portion of tissue.8. The surgical device of claim 1, wherein the first implant is aself-expanding anchor.
 9. The surgical device of claim 8, wherein thefirst implant is disk-shaped.
 10. The surgical device of claim 9,wherein the self-expanding anchor includes a plurality oftissue-piercing teeth configured to penetrate the entire thickness ofthe first portion of tissue.
 11. A surgical device, comprising: a hollowneedle having an inner chamber and a sharp tip configured to pierce atissue; a first self-expanding anchor having a collapsed position and anexpanded position, the first anchor being positionable within the innerchamber when in the collapsed position; a first suture extending throughthe needle and attached to the first anchor; and an actuator configuredto drive the needle containing the first anchor into a firstpredetermined position in a first portion of tissue, wherein the needleis retractable from the first predetermined position to leave the firstanchor in the first predetermined position, and the first anchor isexpandable from the collapsed position to the expanded position uponretraction of the needle.
 12. The device of claim 11, furthercomprising: a second self-expanding anchor having a collapsed positionand an expanded position, the second self-expanding anchor beingpositionable within the inner chamber when the second self-expandinganchor is in the collapsed position; and a second suture extendingthrough the needle and attached to the first anchor, wherein theactuator is configured to drive the needle with the second anchor into asecond predetermined position in a second portion of the tissue, theneedle being retractable from the second predetermined position to leavethe second anchor in a position distally beyond the second portion oftissue, and the second anchor is expandable from the collapsed positionto the expanded position upon retraction of the needle.
 13. The deviceof claim 12, wherein each of the first and second sutures is a braidedsuture.
 14. The device of claim 12, wherein the device includes anactuator configured to distally retract the first suture and the secondsuture into a distal end of the device, thereby pulling the first anchorand the second anchor together, the pulling of the first anchor and thesecond anchor together causing the first portion of tissue to be pulledtoward the second portion of tissue.
 15. The device of claim 14, whereinthe sutures are twisted as they are distally retracted.
 16. The deviceof claim 14, further comprising a clamp configured to join the firstsuture to the second suture and cut excess portions of the first sutureand the second suture distal to the joint of the first suture to thesecond suture.
 17. A surgical system, comprising: a first implantcoupled to a first suture; a second implant coupled to a second suture;and an implant driver configured to position the first implant in afirst predetermined position in relation to a first tissue, and toposition the second implant in a second predetermined position inrelation to a second tissue, the implant driver configured to draw thefirst and second sutures together to bring the implants into appositionthereby bringing the first tissue and the second tissue into apposition,wherein the first and second implants are configured to pierce both thefirst and second tissues at an interface of the first and second tissueswhen the first and second tissues are in apposition.
 18. The system ofclaim 17, wherein the first implant is a first disk and the secondimplant is a second disk.
 19. The system of claim 18, wherein the firstdisk includes a plurality of projections each configured to cut entirelythrough the first tissue and the second disk includes a plurality ofprojections each configured to cut entirely through the second tissue.20. A method, comprising: positioning a first implant in a firstpredetermined position adjacent a first tissue; positioning a secondimplant in a second predetermined position adjacent a second tissue;bringing the first and second tissues into apposition by pulling thefirst and second implants into apposition with each other; and creatingmultiple puncture wounds in each of the first and second tissues withthe first and second implants.